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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06164795
Other study ID # START
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 25, 2023
Est. completion date December 2025

Study information

Verified date December 2023
Source 424 General Military Hospital
Contact Athanasios D Anastasilakis, PhD
Phone 2310381431
Email a.anastasilakis@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

12-month prospective, open-label, multicenter, international, observational study evaluating sequential treatments after osteoanabolics


Description:

Caucasian women with severe postmenopausal osteoporosis who have completed their course with romosozumab or teriparatide will be assigned to one of the following 3 options: i) zoledronate 5mg infusion or ii) denosumab subcutaneous injections or iii) teriparatide (for those previously treated with romosozumab) or romosozumab (for those previously treated with teriparatide). Endpoints: Primary: BMD changes at the lumbar spine at 12 months. Secondary: i) BMD changes at the non-dominant femoral neck and total hip at 12 and 24 months; ii) changes at levels of bone turnover markers throughout the study; iii) incident fractures: vertebral (clinical and morphometric identified on VFA scans) and non-vertebral


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender Female
Age group 50 Years to 85 Years
Eligibility Inclusion Criteria: • Postmenopausal women treated with severe osteoporosis completing their course with romosozumab or teriparatide Exclusion Criteria: - a bone disease other than postmenopausal osteoporosis - use of medications other than romosozumab or teriparatide affecting bone metabolism during the last 12 months before entering the study - creatinine clearance <60 mL/min/1.73 m2 - liver failure - any type of cancer - uncontrolled endocrine diseases - serum 25-hydroxy vitamin D (25-OHD) concentrations lower than 20 ng/mL (50 nmol/L) - hypersensitivity to denosumab or zoledronate or teriparatide or romosozumab or any of the excipients

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Zoledronate
intravenous infusion
Denosumab
subcutaneous injection
Teriparatide
subcutaneous injection
Romosozumab
subcutaneous injection

Locations

Country Name City State
Germany Department of Medicine III and Center for Healthy Aging, Technische Universität Dresden Dresden
Greece , KAT General Hospital Athens
Greece 251 Airforce & VA General Hospital Athens
Greece First Department of Propaedeutic and Internal Medicine, Medical School, National and Kapodistrian University of Athens Athens
Greece 424 General Military Hospital Thessaloniki
Italy Fondazione IRCCS Cà Granda-Ospedale Maggiore Policlinico Milan
Italy Campus Bio-Medico University Roma
Italy Department of Medicine, Surgery and Neurosciences, University of Siena Siena
Italy University-Hospital S. Maria della Misericordia Udine

Sponsors (1)

Lead Sponsor Collaborator
424 General Military Hospital

Countries where clinical trial is conducted

Germany,  Greece,  Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary lumbar spine bone mineral density bone mineral density changes at the lumbar spine at 12 months measured by dual-energy absorptiometry (DXA) baseline to 12 months
Secondary femoral neck bone mineral density bone mineral density changes at the femoral neck at 12 months measured by dual-energy absorptiometry (DXA) baseline to 12 months
Secondary total hip bone mineral density bone mineral density changes at the total hip at 12 months measured by dual-energy absorptiometry (DXA) baseline to 12 months
Secondary P1NP bone turnover (formation) marker baseline, 3 months, 6 months, 12 months
Secondary CTx bone turnover (resorption) marker baseline, 3 months, 6 months, 12 months
Secondary Fractures incident fractures: vertebral (clinical and morphometric identified on VFA scans) and non-vertebral 12 months
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